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Trial Evaluating the Interest of Noninvasive Ventilation in NAVA Mode in Respiratory Decompensations Children With Infantile Spinal Muscular Atrophy Type II (NAVASI)

Primary Purpose

Infantile Spinal Muscular Atrophy

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

NAVA

About this trial

This is an interventional treatment trial for Infantile Spinal Muscular Atrophy focused on measuring Infantile Spinal Muscular Atrophy, Respiratory Decompensations

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age above 1 year and under 18 years
Patient hospitalized in the pediatric intensive care unit.
Acute respiratory decompensation requiring non-invasive ventilation for more than 6 hours.
Patient with traditional NIV support less than 12 hours and still showing an indication for a non-invasive ventilatory support.
Affiliation to the French health insurance organism
Consent signed by the two holders of parental authority for the child participation in the research.

Exclusion Criteria:

Contraindications to the use of NAVA or the setting up of a nasogastric tube.
Hemodynamic instability requiring the use of vasopressor amines, adrenaline, norepinephrine or dobutamine.
Severe respiratory instability requiring imminent intubation or FiO2> 60%, or PaCO2> 80 mmHg.
Limitation of life support treatments discussed or decided.

Sites / Locations

Service de pédiatrie, Hôpital Raymond Poincaré

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single arm

Arm Description

Single arm trial, every patient enroll in this study will follow the same protocol with classic and NAVA mode non-invasive ventilation.

Outcomes

Primary Outcome Measures

Asynchrony percentage

Asynchrony percentage of non-synchronous breath cycles over all cycles of the measurement period, unaided breaths, self-initiated cycles.

Secondary Outcome Measures

Feasibility

Frequency of obtaining an EADi signal

Feasibility

Percentage of effective time spent in activated NAVA mode

Efficacy and tolerance

Efficacy and tolerance: during the whole of the study period (2h30), the monitoring of transcutaneous CO2 pressure (PtcCO2) will be collected.

Efficacy and tolerance

Efficacy and tolerance: during the whole of the study period (2h30), evolution of respiratory rate will be collected.

Efficacy and tolerance

O2 saturation will be collected.

Efficacy and tolerance

FiO2 after 30 and 60 minutes under each ventilation mode will be collected.

Rate of recourse to intubation

Rate of recourse to intubation, patient preference.

Full Information

NCT ID

NCT03395795

First Posted

December 11, 2017

Last Updated

March 28, 2022

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT03395795

Brief Title

Trial Evaluating the Interest of Noninvasive Ventilation in NAVA Mode in Respiratory Decompensations Children With Infantile Spinal Muscular Atrophy Type II

Acronym

NAVASI

Official Title

Controlled Trial Evaluating the Interest of Noninvasive Ventilation in NAVA Mode in Respiratory Decompensations Children With Infantile Spinal Muscular Atrophy Type II

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

February 13, 2018 (Actual)

Primary Completion Date

December 17, 2019 (Actual)

Study Completion Date

October 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The new NAVA® ventilatory mode with the SERVO-i ventilator (Maquet®) uses the electrical activity of the diaphragm (EADi) as a marker for triggering the respiratory cycle. The EADi is captured by the electrodes of a specific catheter (the Edi® catheter) placed in the esophagus as a regular gastric feeding tube, and relayed to the SERVO-i who displays it and delivers respiratory assistance according to measured Edi signal which allows synchronous assistance, proportional to the respiratory efforts of the patient. To date, no measure of the effectiveness of NAVA NAV has been performed in children with neuromuscular pathology whereas this technique could reduce the use of invasive ventilation, very iatrogenic in these fragile subjects.

Detailed Description

This is a prospective, interventional, sequential, open-label research involving ASI II children with acute respiratory decompensation requiring ventilatory support by NIV. Airway pressure, transcutaneous CO2 monitoring and hemodynamic parameters will be recorded continuously during the study, after inclusion of the patient.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infantile Spinal Muscular Atrophy

Keywords

Infantile Spinal Muscular Atrophy, Respiratory Decompensations

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single arm

Arm Type

Other

Arm Description

Single arm trial, every patient enroll in this study will follow the same protocol with classic and NAVA mode non-invasive ventilation.

Intervention Type

Device

Intervention Name(s)

NAVA

Intervention Description

The study has 3 phases: Phase 1: The patient is connected to the SERVOi® ventilator in classic VNI mode, which is parameterized according to the patient's needs and then maintained for 30min for measurements. Phase 2: Switch to NAVA mode (1h). Definition of NAVA parameters: The positive expiratory pressure will not be modified. The NAVA level (the proportionality factor that converts the EADi (microV) to the pressure level in cmH2O was first adjusted according to the actual assisted pressure in the patient in the normal VNI mode. NAVA period: The ventilatory pressure, as well as the EADI is recorded continuously for 30min after a NAVA adaptation period of about 30min. Phase 3: The patient returns to classic VNI mode with Phase 1 ventilatory settings for a 30 minute recording.

Primary Outcome Measure Information:

Title

Asynchrony percentage

Description

Asynchrony percentage of non-synchronous breath cycles over all cycles of the measurement period, unaided breaths, self-initiated cycles.

Time Frame

At baseline

Secondary Outcome Measure Information:

Title

Feasibility

Description

Frequency of obtaining an EADi signal

Time Frame

At baseline

Title

Feasibility

Description

Percentage of effective time spent in activated NAVA mode

Time Frame

At baseline

Title

Efficacy and tolerance

Description

Efficacy and tolerance: during the whole of the study period (2h30), the monitoring of transcutaneous CO2 pressure (PtcCO2) will be collected.

Time Frame

At 30 minutes and 60 minutes

Title

Efficacy and tolerance

Description

Efficacy and tolerance: during the whole of the study period (2h30), evolution of respiratory rate will be collected.

Time Frame

At 30 minutes and 60 minutes

Title

Efficacy and tolerance

Description

O2 saturation will be collected.

Time Frame

At 30 minutes and 60 minutes

Title

Efficacy and tolerance

Description

FiO2 after 30 and 60 minutes under each ventilation mode will be collected.

Time Frame

At 30 minutes and 60 minutes

Title

Rate of recourse to intubation

Description

Rate of recourse to intubation, patient preference.

Time Frame

At baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age above 1 year and under 18 years Patient hospitalized in the pediatric intensive care unit. Acute respiratory decompensation requiring non-invasive ventilation for more than 6 hours. Patient with traditional NIV support less than 12 hours and still showing an indication for a non-invasive ventilatory support. Affiliation to the French health insurance organism Consent signed by the two holders of parental authority for the child participation in the research. Exclusion Criteria: Contraindications to the use of NAVA or the setting up of a nasogastric tube. Hemodynamic instability requiring the use of vasopressor amines, adrenaline, norepinephrine or dobutamine. Severe respiratory instability requiring imminent intubation or FiO2> 60%, or PaCO2> 80 mmHg. Limitation of life support treatments discussed or decided.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aben Essid, MD

Organizational Affiliation

Service de pédiatrie, Hôpital Raymond Poincaré

Official's Role

Study Chair

Facility Information:

Facility Name

Service de pédiatrie, Hôpital Raymond Poincaré

City

Garches

State/Province

Hauts-de-Seine

ZIP/Postal Code

92380

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Trial Evaluating the Interest of Noninvasive Ventilation in NAVA Mode in Respiratory Decompensations Children With Infantile Spinal Muscular Atrophy Type II

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